文档介绍：CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:125469Orig1s000LABELING1HIGHLIGHTSOFPRESCRIBINGINFORMATION-------------------------------CONTRAINDICATIONS------------------------------Thesehighlightsdonotincludealltheinformationneededtouse•(,,).•DonotuseifhistoryofserioushypersensitivitytoTRULICITYoranyTRULICITY(dulaglutide)injection,ponents(,).:2014------------------------WARNINGSANDPRECAUTIONS-----------------------WARNING:RISKOFTHYROIDC-CELLTUMORS•ThyroidC-celltumorsinanimals:pleteboxedwarning.().•DulaglutidecausesthyroidC-•Pancreatitis:-celltumors,(MTC),().studies(,).•Hypoglycemia:WhenTRULICITYisusedwithaninsulin•TRULICITYiscontraindicatedinpatientswithapersonalorsecretagogue(.,asulfonylurea)orinsulin,considerloweringthefamilyhistoryofMTCandinpatientswithMultipleEndocrinedoseofthesulfonylureaorinsulintoreducetheriskofNeoplasiasyndrometype2(MEN2)().hypoglycemia().•HypersensitivityReactions:DiscontinueTRULICITYifsuspected.----------------------------INDICATIONSANDUSAGE---------------------------MonitorandtreatpromptlyperstandardofcareuntilsignsandTRULICITY™isaglucagon-likepeptide(GLP-1)receptoragonistsymptomsresolve().indicatedasanadjuncttodietandexercisetoimproveglycemic•RenalImpairment:().•es:TherehavebeennostudiesestablishingL